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FDA Authorizes First Over-the-Counter Hearing Aid Software
- todotask 2y agoHow do I deal with itchiness? Having trying to wear for a few seconds, can be annoying after been wearing hearing aid for decade.
- niij 2y agoWill this support CROS?
- neilv 2y agoConsider the plausible scenario of Apple developing a superior hearing aid -- a medical device. If that happens, will people be able to use best medical device without being subject to the various liberties that tech companies take with users -- violating privacy, and exercising leverage to other purposes? We've become acclimated to expect violation from the "tech" industry, but what about the medical field?
- candiddevmike 2y agoThe FDA, for all of its warts, is pretty good at curbing bad behavior like this. All medical devices are pretty rigorously controlled, to the point where you can't really add anything to it that isn't absolutely necessary for the device to function. And if you do, there's an encyclopedia worth of paperwork you're going to have to write to defend why the functionality is needed. FDA likes to "duck type" things, and if your duck doesn't look like the other ducks, you need to create a new animal or make your duck look like other ducks.
- neilv 2y agoInteresting. Do you think the FDA will be more proactive and sharper, than regulatory authorities that got confused in the past by tech companies (Airbnb, Uber, RealPage (YieldStar), and others)?
- candiddevmike 2y agoThe opposite, they're going to be ridiculously stubborn and require all of these high tech gadgets to be "less". The I in FDA stands for innovation.
- chrisweekly 2y ago> "The I in FDA stands for innovation." LOL. I hadn't seen this before. Quote? Or did you coin it?
- gwern 2y agoEspecially here. Expecting good faith in hearing aid regulation - from the FDA?! Remember, Congress authorized OTC hearing aids back in the Trump administration, in August 2017 (https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_Act_of_2017 https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...). For perspective, GPT-1 didn't even exist yet. But the FDA slow-walked it so long that the Biden administration had to intervene (and is now trying to claim credit for it all, of course), which is part of why the OTC hearing aid explosion has taken so long, been so tentative and slow, and you're only seeing it really taking off the past 2 years or so.
- tomrod 2y agoIf they hadn't intervened, would it have happened?
- gwern 2y agoHard to say. They could have fiddled with the rules to make it really unappetizing and kill the market, or slowwalk every last thing (how many vaping products have been approved?). It could have taken many more years and been a lot worse, which is a tragedy for the many, many old people who seriously need it. (Like my grandfather. I also appreciate it, because while OTC hearing aids are - for now - too weak for my hearing loss, it's providing much more competition for the prescription hearing aid oligopoly and I'm benefiting indirectly. The jump between my hearing aids from 2017 to the pair I bought this year is the largest jump in quality I've heard in my hearing aids in like 20+ years.)
- deleted 2y ago[deleted]
- sureIy 2y agoI think this event proves you absolutely wrong. They approved hearing aid “software”, meaning it can run on arbitrary hardware that may or may not have the restrictions you’re talking about… as part of other “software”
- mike_d 2y ago> We've become acclimated to expect violation from the "tech" industry, but what about the medical field? Oh, you sweet innocent child. Look at price gouging on EpiPens, J&J "lifelong" hip implants needing replacement every few years, insulin pumps with proprietary batteries, glucose monitors that actively prevent you from reading data, etc. Big bad tech companies don't hold a candle to the medical industry.
- deleted 2y ago[deleted]
- StressedDev 2y agoHow is Apple violating people’s privacy? They have done a far better job than other companies from what I'm have seen.
- zie 2y agoI mean they are the best of the big tech companies, by a country mile, but that's not really saying a lot. If you want the full details, go read the privacy policy with a skeptic's perspective.
- Angostura 2y ago“Do your own research “
- thowawatp302 2y agoEverything in there seems fine to me, not sure what you’re talking about
- kevin_thibedeau 2y agoScanning for image hashes on everyone's phone is one.
- echoangle 2y agoThey aren't doing that currently though, right? The only thing I remember is the NeuralHash thing which was delayed and then never came.
- cm2012 2y agoBig tech - including even Meta but definitely including Apple - have an insanely better track record of keeping user data safe than traditional non-tech companies.
- olalonde 2y agoIf you take away economic incentive from Apple, the plausible scenario is that Apple is simply not going to develop such superior devices.
- abtinf 2y ago> This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed device”? How much more onerous is the normal pathway?
- tootie 2y agoSony already has OTC hearing aids on the market
- CharlesW 2y agoNeat: https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-hearing-aid https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-... So what does "first OTC Hearing Aid Software" mean, given that both are hardware/software systems?
- squidgedcricket 2y ago> Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed device”? Nope, they'd use the 510k process, which is less onerous than de novo. De novo is a quicker alternative to the traditional path for brand new classes of devices. The 510k process is used to develop a new device within an existing class.
- xucheng 2y agoInterestingly, in the end of the article, the FDA links to an old article hosted on web.archive.org[1] even though the linked article was originally published by FDA themselves. Considering the linked article was only published at 2022, a merely 2 years ago, maybe the FDA should do more to prevent dead links. [1]: https://web.archive.org/web/20221028042729/https:/www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans https://web.archive.org/web/20221028042729/https:/www.fda.go...
- bigiain 2y ago> maybe the FDA should do more to prevent dead links Perhaps government departments (and companies) taking advantage of archive.org storing their old docs should be appropriately supporting them?
- FinnKuhn 2y agoI don't know how much money the internet archive has received from official US government institutions, but they do receive at least some as you can see from their list of foundations that help with funding them: https://archive.org/about/ https://archive.org/about/
- galleywest200 2y agoThis could also make is more difficult for new administrations to "disappear" documents from government sites by storing them on an archival site.
- Nursie 2y agoI’m very positive about this development. I don’t personally need hearing aids (yet) but I know people that do, and dear god are they expensive pieces of equipment. Even if the AirPods aren’t perfect for everyone (not everyone wants in-ear devices) a big name like this getting in at that price-point might shake up the market.
- duskwuff 2y ago> I don’t personally need hearing aids (yet) but I know people that do, and dear god are they expensive pieces of equipment. They aren't as bad as they used to be. You can get over-the-counter hearing aids in the $200-500 range nowadays. Even so, at $250, AirPods Pro are in a pretty good spot. The main drawback I see is that the earbuds don't have all-day battery life; users will need to recharge them in the case periodically.
- BOOSTERHIDROGEN 2y agoany recommendations ?
- thebigman433 2y agoYou should go to Costco and try a bunch if you have one near you. Its hard to recommend specific hearing aids to people without knowing what they need. If you dont have a Costco, go to any reputable hearing aid store near you and try from their stock
- Nursie 2y agoJust to echo what the other poster said - Costco seem to have very good prices and will give you a free hearing test with an audiologist (in Australia anyway) Their range is fairly limited, but not necessarily in a bad way. Compared to what other audiologists recommend/prescribe, Costco's stuff was about half the price. OTC hearing aids - no idea.
- Nursie 2y agoI guess the big question there is, which market segment will the airpods be comparable to - OTC or prescription? Because the 'good' hearing aids cost thousands of dollars, and a lot of their added value is in various forms of sound processing. I can see apple doing quite well at that. > The main drawback I see is that the earbuds don't have all-day battery life; users will need to recharge them in the case periodically. Yeah definitely, though if we are comparing them to 'good' hearing aids then at that price you could buy two pairs and rotate them through the charging case and still come out ahead.
- mgerdts 2y agoI’m conflicted on use of AirPods as hearing aids. I use one hearing aid and have normal hearing in the other ear. I often listen to things on my phone over the one hearing aid. It would be nice to have stereo. For this reason, AirPods for both listening to stuff and hearing assistance would be great. On the other hand, when I see someone wearing AirPods I assume they are listening to something else or are otherwise trying to shut the world out. If I were wearing them to be able to engage more, I think I would just be sending the opposite message.
- garyfirestorm 2y agoThis problem could be solved easily. One could put some kind of tiny sticker on their AirPods - it would take sometime for it to become mainstream - like an orange color ring - indicating the user is using the AirPods as hearing aids. (This is a people problem…)
- wpollock 2y agoThe answer is handicap hang tags, like those used in cars, but worn as earrings. <wink>
- deleted 2y ago[deleted]
- hunter2_ 2y agoThe sticker/paint could change all of the white into a skin tone, the way many hearing aids are. Maybe similar to wrapping a car with vinyl, or nail polish.
- sneak 2y agoSome RGB LEDs in the airpods that change color depending on the mode could also achieve this.
- ChrisMarshallNY 2y agoThe issue would be battery use. The batteries in these things are tiny, and using them as hearing aids could mean longer use. Having a phone lockscreen indicator of status would be a good way to show this. I think the phone interface for audiograms is ridiculously complex. They need to improve that.
- userbinator 2y agoThe rule enabled consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist Is it just me or does this article sound (pun intended) a bit tone-deaf? All this talk of them "authorizing", when earphones with built-in mics, transparency modes, and adjustable equalisers have existed for years before this, available for everyone to purchase, and can function as a "hearing aid".
- adgjlsfhk1 2y agoAuthorization is a big deal. It means it can be payed for by insurance or explicitly prescribed.
- deleted 2y ago[deleted]
- herpderperator 2y agoIt's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.
- playingalong 2y agoI don't think they can promise. But in a formal process with so many steps involved, you know what else is left to be done. And if there's nothing left, you assume "very soon" completion. Also Apple's announcement was kind of a pressure put on the gov: "hey, enough, unless you want everyone angry at you".
- ivoflipse 2y agoIf you've submitted a 510k for your medical device, you can advertise it as "510k pending". There is a risk that you never receive the clearance or approval, but in this case Apple probably knew they had already addressed any feedback the FDA had so it was very likely there would be no further stumbling blocks
- sqs 2y agoRule of law FTW! Governments can't usually promise timelines, but when the process is well documented and predictable, that is a very good thing.
- sneak 2y agoLiterally nobody wants the government telling them what kind of headphones they are allowed to wear. This is a failure of the rule of law.
- deleted 2y ago[deleted]
- viherjuuri 2y agoThe government is not telling you which headphones you can wear. They are saying that these particular headphones work well enough as a hearing aid that it is ok that market them as such. This protects you from quacks that claim their device is a hearing aid but that doesn’t actually work.
- 14 2y agoThis is so cool to see. As a health care worker I see lots of people who simply can not afford heating aids as they run for thousands of dollars and then things like they hop into a shower and they stop working happen all the time. What a lot of people don’t realize is that hearing loss is a loss of ability to hear certain frequencies. You can’t simply turn up the volume although that does help to some degree. So what happens is you see a doctor who determines what frequency loss you have and the hearing aid when it picks up that frequency shifts it to another frequency that you can hear. So I do see why up until now ya it was regulated. We don’t want some company selling a device that simply cranks the volume and potentially causes more damage. But with today’s technology we are more then ready for this to be a reality. With an app we can offer hearing tests and determine what areas the client needs improved. This I feel will be a game changer for some. The only thing I wonder about is how well do air pods hold up to waxy ears? With regular hearing aids they need cleaning and often have things like a wax trap which is a tiny plug that catches wax and can be swapped out easily.
- left-struck 2y agoThis is a minor point but cranking the volume doesn’t necessarily mean hearing loss. You could for example have a device that amplifies external sound so that you your hearing is enhanced over all frequencies but has a max volume that it will not exceed. This compresses the dynamic range and makes the quietest sounds easier to detect. It would reduce your ability to distinguish sounds in a noisy environment though I imagine.
- bagels 2y agoThey need to legalize glasses.
- sneak 2y agoZenni has historically been good about shipping without a prescription (not sure about present day), and you can buy contacts in Europe without a prescription and have them shipped, although the shipping is a bit higher.
- ewoodrich 2y ago> Zenni has historically been good about shipping without a prescription (not sure about present day) They still are. As long as you don’t confuse them by including a few pairs of glasses with similar but slightly different values in the same order. Then they might demand an actual copy of a prescription. Don’t ask me how I know...
- hungie 2y agoFDA with a reasonable bar - demonstrate that this is equivalent to a professional fitting. I'll take any opportunities for assistive technology to be a cheaper option.
- sneak 2y agoHearing aids are neither food nor drugs. Same goes for glasses and contact lenses, and CPAP machines. These should never have required approval or prescriptions in the first place. So many people are kept from getting what they need by these arbitrary restrictions.
- wtallis 2y ago> Hearing aids are neither food nor drugs. Do you really believe that the FDA needs to be renamed before it is reasonable for them to be the agency responsible for regulating medical devices? Is there a different agency you think would be a better fit?
- IncreasePosts 2y agoThe NIH?
- wtallis 2y agoThat's purely a research organization, with no existing regulatory role.
- IncreasePosts 2y agoSure. But it would work if you're just looking at names, as it seemed OP was doing.
- avianlyric 2y agoWhile we’re at it, the FDA shouldn’t regulate pacemakers, glucose monitors, artificial hearts, cochlear implants, hip replacement joints, or any other kind of surgical implant. None of them are either food or drugs, and so many people are prevented from getting what they need thanks to these arbitrary restrictions! Hmmm, on second thought, I’m not sure allowing ali express implants to be marketed the same as rigourously tested implants, with clear evidence of safety and efficacy, is such a great idea.
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- car 2y agoWith the AirPods now officially becoming hearing aids, it will hopefully reduce the stigma and attitude towards hearing aids and allow many more people to realize how bad their hearing actually is. I have been wearing hearing aids for a few years now (Phonak). I've also used the AirPods Pro with the accessibility audiogram feature (basically making them hearing aids), which is really good and has also been around for a few years. I'm very glad, that Apple has made this official and even gotten FDA approval. When I started to loose my hearing a decade ago, for a long time I refused to wear hearing aids, probably due to the perceived stigma. Even though it made life harder and harder -- imagine work meetings with a mumbling boss or me accusing my family to intentionally whisper -- it took years to change my mind. In hindsight I should have gotten hearing aids years sooner. My 'real' hearing aids are nothing short of a technological marvel. They are tiny and run for a few days on zinc-air batteries (312/Costco but made by Varta), while providing all-day BT streaming. Btw, funny how most hearing aid brands come from Denmark. In contrast, the AirPods run out after a few hours and are also destined to become landfill due to their built in battery.
- whatdidyousay 2y agoHow have the Phonak's been? I only learned of them recently - I've been wearing Oticons for a few years and have never been super impressed. I may be ready to drop $$ for my next pair..... do you work with an audiologist or did you do everything at Costco?
- car 2y agoI got them through an in network hospital audiology department, so paid by health insurance. For out of pocket Costco looks good to me. They have special models that are a little less fancy than the top of the line stuff, from name brand manufacturers. I also checked out earlens.com, a pretty cool concept that’s supposed to be superior in audio quality. But they are pricey, and need to be fitted by a doctor/audiologist with a transducer that sits directly on the eardrums (and stays in your ear canal) and is driven by induction. Ultimately turned off by cost ($12k/pair). I think the technology in hearing aids has profited from the advances in chip manufacturing [1]. So the latest models may also be on 5nm and thus have more transistors for fancy AI and longer battery life. You may have a better experience nowadays. [1] https://esg.tsmc.com/en-US/articles/106 https://esg.tsmc.com/en-US/articles/106
- pcardoso 2y agoOne of my kids was born with a slight hearing loss and I think this is huge. We got from the local health service some basic hearing aids that cost around 1000 euro but we are contemplating buying some high-end Phonak devices that are around 5000 euro as recommended by some experts. In comparison to this the AirPods (280 euro?) are almost free.
- tootie 2y agoOTC hearing aids are now as cheap as $80 USD. I'm sure they're not the best, but it makes the tech incredibly accessible. Sony, Jabra, Eargo ones are more expensive than airpods, less than prescriptions. Not sure how they will stack up to airpods. https://www.jlab.com/products/hear-otc-hearing-aid-graphite https://www.jlab.com/products/hear-otc-hearing-aid-graphite
- systemtest 2y agoDoes your nations healthcare system not cover that?
- amne 2y agocue teenagers with "hearing problems" so they must wear the pods during classes in 3 .. 2 ..
- dsr_ 2y agoWhat's your actual complaint? Is it that teenagers sometimes have hearing issues? That's definitely true; many people are born Deaf or with hearing impairments. Some people get injured. Is it that teenagers might fake having hearing issues in order to wear pods? Either they will be paying attention in class or they won't; this will be obvious from their grades shortly.
- talldayo 2y agoThe "actual complaint" is that Apple made hearing aids indistinguishable from an entertainment device. There's nothing wrong with taking initiative to a good thing, but you can absolutely pave the road to hell with good intentions. People would be rightfully outraged if Tesla drivers could ignore the road to play The Witcher 3 at 50mph on the freeway. Saying something like "either they will crash or they won't" isn't going to assuage the problem or change the design issue. The danger is going to persist as a result of first-party design oversight.
- llbeansandrice 2y agoPlaying video games when you’re supposed to be piloting a half ton death trap isn’t the same as teenagers lying to authority.
- autoexec 2y agoThe problem isn't really the lying though is it. It's the fact that they're not being educated if they aren't paying attention.
- HeyLaughingBoy 2y agoWorse. It's probably a bit over 2 tons.
- dav43 2y agoI am surprised the size of their study where they made conclusions was only 118 ppl. I would have thought a much larger study is required.
- _fat_santa 2y agoThis is huge. Previously if you were hard of hearing, a pair of hearing aids could cost upwards of $2,000. Now Apple just brought that price down to ~$250. Even if you use them everyday and assume a shelf life of 1.5yrs (which is roughly mine and others' experience with AirPods), you would be replacing your Airpods for 12 years before the cost caught up with a single pair of hearing aids. Even if you think Airpods are not on the same bar as regular hearing aids, this will certainly help depress market prices. Every manufacturer will probably start releasing sub $1000 hearing aids just to not get destroyed by Apple.
- HumblyTossed 2y ago> This is huge. Previously if you were hard of hearing, a pair of hearing aids could cost upwards of $2,000. Now Apple just brought that price down to ~$250. Woah there fella. Hearing aids last a very long time before needing a new battery. AirPods needs to be charged several times a day. That's a bit of an inconvenience. As is some hearing aids are made to fit one's ear. Where as AirPods are 3 sizes fits all.
- jeffhuys 2y agoThat’s a much, MUCH lower barrier of entry, though, fella… and that can be celebrated in my opinion
- HumblyTossed 2y agoIt's helpful, sure, but it's not the same thing.
- echoangle 2y agoJust to be pedantic: AirPods Pro 2 come with 4 sizes for tips. Also, I'm sure you can get third-party tips with different shapes if you wanted to.
- deleted 2y ago[deleted]
- mannyv 2y agoThis also means that the Apple ecosystem is HSA and FSA eligible.
- coupdejarnac 2y agoI made a hearing aid app for the iPhone nearly 10 years ago. It was nearly impossible to get anybody to pay $10 or less for it.Also, there is/was a FDA exception for mobile apps, which kind of obviated the need for the grad school class i was taking at Stanford about getting medical devices FDA approved.
- philip1209 2y agoIs it possible to spend FSA/HSA funds on medically-necessary Apple products/services?
- ganoushoreilly 2y agoThat's a lingering question right now as the software was approved, but not specifically the hardware. I suspect it would be able to be covered, but as with any of those rules, it's kinda murky. I suspect if it is, we'll see some interesting advertising / marketing from 3rd party resellers.
- philip1209 2y agoMakes sense. Would be great to see iPhones / Apple Watches covered for diabetic CGM users, too.
- HeyLaughingBoy 2y agoIt's a very good question and Apple may already have an answer. One of the interesting things I learned in my time building medical devices is the role of insurance reimbursement in the product development process. Before introducing a new device, or a new (blood) test, one of the questions Marketing has to answer is how difficult it will be to get reimbursement from insurance in the US. It sounds kind of icky, but it's a real concern. If insurance companies won't reimburse for a particular test or use of a device, then the users are far less likely to buy it, or in the case of a test, the physician may have to warn the patient that their insurance isn't likely to pay for it. This will probably lead the manufacturer to decide that it's too risky to proceed with development.
- deleted 2y ago[deleted]
- ohadpr 2y agoSpeaking of the AirPods becoming actual hearing aides - how will we reconcile the fact that it is not socially acceptable to wear AirPods when speaking with someone? Even if you get to explain ‘oh my AirPods are functioning as a hearing aide’ you likely won’t be able to explain that to other people noticing the conversation and thinking to themselves ‘oh that’s douchey, not taking our your AirPods when talking to someone’. I just really wonder if this will be able to make wearing AirPods while talking to other people socially acceptable because the current presumption is likely that they are not behaving nicely.
- ChrisArchitect 2y agoRelated: AirPods Pro 2 adds 'clinical grade' hearing aid feature https://news.ycombinator.com/item?id=41491191 https://news.ycombinator.com/item?id=41491191
- ChrisArchitect 2y agoRelated Apple study from May: Apple Hearing Study shares preliminary insights on tinnitus https://news.ycombinator.com/item?id=41491121 https://news.ycombinator.com/item?id=41491121
- detourdog 2y agoI see this as a major advance for ADA compliance for headphones. This may take a few years but audiogram editing is going to become minimal specification.
- adolph 2y agoDo glasses next